SUSAN DANA JONES, Ph.D. Vice President and Principal Consultant

Transcription

1 SUSAN DANA JONES, Ph.D. Vice President and Principal Consultant (m) Profile An industry veteran with over 30 years of experience in biopharmaceutical product discovery and development, helping shepherd multiple products from discovery through first in human clinical trials and beyond. Versed in integration of discovery and development, generation of production cell lines, design of effective manufacturing strategies, preparing regulatory submissions, and conducting CMC due diligence. Experience BioProcess Technology Consultants, Inc., Woburn, MA Vice President and Principal Consultant (2014-present) Vice President and Senior Consultant ( ) Senior Consultant ( ) Company officer providing CMC consulting services to biopharmaceutical companies in the areas of antibody discovery and development, outsourcing, technology transfer, process development, manufacturing, and CMC regulatory. Expert in program management and strategic planning. Harpoon Therapeutics, Inc., South San Francisco, CA Senior Vice President, Product Development Member of Executive Leadership team. Contribute to company strategic initiatives. Manage development of portfolio of novel T-cell engager molecules, including selection and management of contract development and manufacturing sites and preparation of regulatory submissions. ImmuRx Inc., Lebanon, NH Vice President, Development Manage antibody discovery program, define and implement strategic development program for complex immunotherapeutic product, identify, qualify, and select contract organizations to support development program. Northeastern University, Boston, MA Guest Lecturer Teach sections on biopharmaceutical discovery and development as part of graduate level Drug Discovery and Development program. Massachusetts College of Pharmacy, Boston, MA Adjunct Associate Professor Provide lectures in graduate courses in drug development, lead or participant in multiple Master s Degree Thesis committees Present present BioProcess Technology Consultants, Inc. 12 Gill Street Suite 5450 Woburn, MA 01801

2 Serenex, Inc., Durham, NC Senior Vice President, Corporate Development Founder and Officer of start-up biotechnology company utilizing unique highthroughput screening technology to accelerate drug discovery. Waratah Pharmaceuticals Inc., Montreal, Quebec, Canada Vice President Founder and Officer of start-up company developing a proprietary and novel diabetes therapy. Responsible for management of all process development and manufacturing activities. Dyax Corp., Cambridge, MA Vice President, Technology ( ) Director, Technology Strategy ( ) Responsible for phage display licensing strategy. Actively participated in company financing, performed technical due diligence for acquisition of TargetQuest, initiated, managed, and obtained grant funding for drug discovery program for multiple sclerosis. IntraImmune Therapies Inc., Boston, MA Director of Research Directed all research activities, co-authored business plan, presented company technology to investors, and negotiated collaboration agreements. Virus Research Institute, Cambridge, MA Senior Research Scientist Designed and executed pre-clinical assays for new gene therapy product. Wrote gene therapy protocols for submission to regulatory agencies. Peptimed, Inc., Cambridge, MA Senior Research Scientist Built and operated molecular and cell biology laboratories to support integrated drug discovery and development efforts for the company; oversaw team of three technicians. Dana Farber Cancer Institute, Boston, MA Staff Research Scientist ( ) Post-Doctoral Fellow ( ) Cloned and sequenced genes up-regulated by treatment of cells with growth factors to determine impact on cellular metabolism and growth properties; cloned and sequenced two PDGF receptors from primary human cell cultures Education University of California, San Francisco, CA Ph.D., Genetics Harvard University, Cambridge, MA B.A., magna cum laude, Biochemistry Susan Dana Jones, Ph.D. Page 2

3 Board Memberships Gene Solutions LLC, Charlottesville, VA Board of Directors BioProcess International Editorial Advisory Board 2010-Present 2004-Present Professional Associations New England Women in Science and Engineering 2013-Present Recent Presentations Jones SD. Expression Challenges of Engineered Proteins. Presented at KNECT 365 BioProcess International; 2018 Sept 4 7; Boston, MA Jones SD. Speed to IND: Risks to Achieving Aggressive Breakthrough/Fast-track Product Timelines. Presented at IBC s BioProcess International West; 2017 Feb 27 Mar 2; San Francisco, CA Jones SD. Multiplexing for Efficient Product Development. Presented at IBC s BioProcess International West; 2016 Mar 14 17; Oakland, CA Jones SD. Engineering product quality into early development activities. Presented at Healthtech Institute s BioProcessing Summit; 2013 Aug 19-23; Boston, MA. Jones SD. Analytical Methods to support IgM development. Presented at Dechema s fourth annual Conference on IgM Development; 2013 Apr 23-24; Frankfurt, Germany. Jones SD. Quality by design during cell line development. Presented at IBC s Biopharmaceutical Development and Manufacturing Week; 2013 Feb 27-Mar 1; Huntington Beach, CA. Levine HL, Jones SD. Economical approaches to meeting global demand for high value biopharmaceuticals. Presented at Informa Life Sciences' Ninth Annual BioProcess International European Conference and Exhibition; 2013 Apr 17-18; Dusseldorf, Germany. Jones SD. Meeting the challenges of applying PAT to biopharmaceutical manufacturing (Webinar). Presented via World Trade Group s Webinars; 2012 Dec 6. Available from: Jones SD, et al. High throughput process development for vaccines preconference workshop. Presented at Informa Life Sciences Vaccines Europe Conference; 2012 Dec 3-6; Brussels, Belgium. Jones SD. Defining TPP enables application of QbD to cell line development. Presented at Oxford Global s Cell Culture and Bioprocessing Congress; 2012 Nov 5-6; London, United Kingdom. Jones SD. GL-2045: Applying QbD to cell line development of a complex product. Presented at Informa Life Sciences Bioproduction; 2012 Oct 24-25; Berlin, Germany. Jones SD. Single use options for vaccine manufacturing. Presented at Terrapinn s 12th Annual World Vaccine Congress; 2012 Apr 10-13; National Harbor, MD. Jones SD. Quality by design: a new paradigm for development? Presented at the Eighth Annual bioprocessuk Conference; 2011 Nov 30-Dec 1; Glasgow, Scotland. Susan Dana Jones, Ph.D. Page 3

4 Jones SD. Quality by design in vaccine development and manufacturing preconference workshop. Presented at Informa Life Sciences Vaccines Europe Conference; 2011 Nov 29-Dec 1; Brussels, Belgium. Jones SD. QbD on a Budget-Applying the Principles of QbD to Early Process Development. Presented at Informa Life Sciences Bioproduction; 2011 Oct 19-20; Berlin, Germany. Jones SD. Quality by design in vaccine development and manufacturing. Presented at World Vaccine Manufacturing Congress 2011; 2011 Oct 11-12; Lyon, France. Jones SD. Target Product Profiles in Early Development and their Role in Quality by Design and Design Space. Presented at IBC USA Preclinical Scale Bioprocessing; 2011 Sep 12-14; San Diego, CA Jones SD. Quality by design in influenza vaccine development and manufacturing. Presented at Cambridge Healthtech Institute s Sixth Annual Immunotherapeutics and Vaccine Summit (ImVacS); 2011 Aug 15-18; Cambridge, MA. Jones SD. Technical and regulatory considerations in rapid scale-up of vaccine manufacturing processes. Presented at Informa Life Sciences Vaccines Europe Conference; 2008 Dec 2-3; Brussels, Belgium. Jones SD. Commercializing cell therapy-lessons learned from MAbs. Presented at BIO International Convention Jun 25-28; Washington DC. Jones SD. What do regulatory agencies really expect for comparability during process optimization and scale-up? Presented via Cambridge Healthtech Institute Conferences; 2010 May 26 and Oct 28. Available from: Full presentation list is available upon request Recent Publications Blumberg, LJ, Humphries JE, Jones, SD, et al. Reduction of circulating levels of IgG and IgG immune complexes in humans by blocking an intracellular IgG receptor, FcRn Manuscript in preparation Pyzik M. et al. Hepatic FcRn regulates albumin homeostasis and susceptibility to liver injury. Proc Natl Acad Sci U S A Apr 4;114(14):E2862-E2871. doi: /pnas Epub 2017 Mar 22. Doig, A, Jones SD. From CMO to CDMO: Opportunities for specializing and innovation. BioProcess Int May; 14(Suppl) Jones SD et al. High throughput process development approaches for biopharmaceuticals. Am Pharm Rev Jan-Feb;18(1):44-8. Ecker DM, et al. The therapeutic monoclonal antibody market. mabs 2015 Jan-Feb;7(1):9-14. Jones SD, Ecker DM. Using genomic analysis to improve mammalian cell culture for biopharmaceutical production. Pharm Processing Oct; 28(8):24-6. Levine HL, Jones SD, et al. Single-use technology and modular construction enabling biopharmaceutical facilities of the future. BioProcess Int Jan;11(Suppl 4):40-5. Susan Dana Jones, Ph.D. Page 4

5 Levine HL, Jones SD, et al. Efficient, flexible facilities for the 21st century. BioProcess Int Dec;10(Suppl 11): Jones SD, et al. Process validation with a CMO. In Rathore AS, Sofer G, editors. Process validation in manufacturing of biopharmaceuticals. 3rd ed. Boca Raton (FL): CRC Press; 2012 May. p Magil SG, Jones SD, et al. Development of a biopharmaceutical is complex. Pharm Processing Oct;27(9):32-5. Jones SD, et al. Ensuring reliable scale-up of biopharmaceutical production. Pharm Processing Aug;27(7):16-7. Jones SD, et al. The emerging challenges in cell therapy manufacturing- solutions from monoclonal antibodies. BioProcess Int Mar;10(Suppl 3):4-7. Jones SD, et al. Learning curve-the emerging field of cell therapeutics. Eur Biopharm Rev Winter;58: Ecker DM, Jones SD, et al. The state of mammalian cell culture biomanufacturing. Woburn (MA): BioProcess Technology Consultants, Inc.; 2011 Dec p. Available from: Jones SD. Predicting manufacturability during biopharmaceutical discovery. Pharm Outsourcing Apr;12(2):20-28 Levine HL, Jones, SD, et al. The ongoing challenges of applying QbD to biopharmaceutical products. BioProcess Int Jan;1:64. Jones SD. The Immunotherapeutics and Vaccine Summit - CHI's Fifth Annual Meeting - Novel vaccines: adjuvants and delivery systems: part 1. Idrugs Oct;13(10): Jones SD. The Immunotherapeutics and Vaccine Summit - CHI's Fifth Annual Meeting - Novel vaccines: adjuvants and delivery systems: part 2. Idrugs Oct;13(10): Jones SD, et al. CMC activities for development of MAbs: critical steps to reach IND with a therapeutic antibody. Contract Pharma Apr;12(3):60-3. Jones SD, et al, contributor. The development of therapeutic monoclonal antibody products. Levine HL, Jagschies, G, editors. Molnlycke (SE): Elanders Sverige AB; 2010 Feb. 338 p. Jones SD, et al. Advances in the development of therapeutic monoclonal antibodies. BioPharm Int Oct;20(10): Thompson RE, et al. Validation of recovery and purification processes. In Agalloco J, Carleton FJ, editors. Validation of pharmaceutical processes. 3 rd ed. New York: Informa Healthcare USA; p Seymour P, et al. Successful CMO selection: CMC strategies for outsourcing biopharmaceutical manufacturing. BioProcess Int Sep;4(Suppl 5):26-9. Jones SD. Levine HL. Managing biopharmaceutical vendor identification and selection through use of a request for proposal. Amer Pharm Outsourcing Jul-Aug;6: Susan Dana Jones, Ph.D. Page 5

6 Jones SD. Levine HL. Biotech emerges in India: a changing business and legal environment drives the expansion. BioExecutive Int May:50-3. Jones SD. Levine HL. Impact of the EU Clinical Trials Directive and other recent regulatory changes on the manufacture of biopharmaceuticals. Preclinica Sep-Oct;2(5): Full publication list is available upon request Patents Magil SG, Jones SD, et al, inventors; Waratah Pharmaceuticals, Inc., assignee. Epidermal growth factor protein and gene, and methods of use therefor. United States patent US 7,037, May 2. Blumberg LJ, Blumberg RS, Jones SD et al., inventors ; Syntimmune, Inc. assignee. Humanized, affinity matured anti-fcrn antibodies. Filed May 12, International Patent Application No.: PCT/US2016/ Susan Dana Jones, Ph.D. Page 6